NL-OMON51062已完成不适用
Safety and preliminary protective efficacy of genetically attenuated Pf*mei2 (GA2) malaria parasites in healthy Dutch volunteers - GA2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Subject is aged >= 18 and <= 35 years and in good health.
- •2. Subject has adequate understanding of the procedures of the study and agrees
- •to abide strictly thereby.
- •3. Subject is able to communicate well with the investigator, is available to
- •attend all study visits.
- •4. Furthermore, the subject will remain within the Netherlands from day -1 till
- •day +28 after each parasite exposure. After exposure to parasites, subjects
- •have to be reachable by phone (24/7) from day -1 until day 35.
- •5. Subject agrees that his/her general practitioner (GP) will be informed about
- •participation in the study.
- •6. Subject agrees to refrain from blood donation to Sanquin or for other
- •purposes throughout the study period and for a defined period thereafter
- •according to Sanquin guidelines (three years minimum, depending on serology).
- •7. Non-pregnant, non-lactating, fertile (i.e., have a uterus and are neither
- •surgically sterilized nor post-menopausal) female subjects agree to use
- •adequate contraception and to not breastfeed for the duration of study.
- •8. Subject agrees to refrain from intensive physical exercise (disproportionate
- •to the subjects* usual daily activity or exercise routine) for twenty-one days
- •following each immunization and during the malaria challenge period.
- •9. Subject signs informed consent.
排除标准
- •1. Any history, or evidence at screening, of clinically significant symptoms,
- •physical signs or abnormal laboratory values suggestive of systemic conditions,
- •such as cardiovascular, pulmonary, renal, hepatic, neurological,
- •dermatological, endocrine, malignant, haematological, infectious,
- •immune-deficient, psychiatric or other disorders, which could compromise the
- •health of the volunteer during the study or interfere with the interpretation
- •of the study results. These include, but are not limited to, any of the
- •a. Body weight <50 kg or Body Mass Index (BMI) <18.0 or >30.0 kg/m2 at
- •b. A heightened risk of cardiovascular disease, defined as:
- •i. An estimated ten-year risk of fatal cardiovascular disease of >=5% at
- •screening, as determined by the Systematic Coronary Risk Evaluation (SCORE).
- •ii. History, or evidence at screening, of clinically significant arrhythmia*s,
- •prolonged QT-interval or other clinically relevant ECG abnormalities; or
- •iii. A positive family history of cardiac events in first- or second-degree
- •relatives (according to the system used in medical genetics) <50 years old.
- •c. Functional asplenia, sickle cell trait/disease, thalassemia trait/disease or
- •G6PD deficiency.
- •d. History of epilepsy in the period of five years prior to study onset, even
- •if no longer on medication.
- •e. Positive HIV, HBV or HCV screening tests.
- •f. Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or other
- •drugs that might have an influence on the immune system (excluding inhaled and
- •topical corticosteroids and incidental use of oral anti-histamines), within
- •three months prior to study onset or expected use of such during the study
- •g. History of malignancy of any organ system (other than localized basal cell
- •carcinoma of the skin), treated or untreated, within the past five years.
- •h. Any history of treatment for severe psychiatric disease by a psychiatrist in
- •the past year.
- •i. History of drug or alcohol abuse interfering with normal social function in
- •the period of one year prior to study onset, positive urine toxicology test for
- •cocaine or amphetamines at screening or prior to exposure to parasites or
- •positive urine toxicology test for cannabis prior to exposure to parasites.
- •2. For female subjects: breastfeeding, or positive urine pregnancy test at
- •screening or prior to immunization or prior to CHMI.
- •3. Any history of malaria, positive serology for Pf, or previous participation
- •in any malaria (vaccine) study or CHMI.
- •4. Known hypersensitivity to or contra-indications (including co-medication)
- •for use of atovaquone/proguanil or artemether/lumefantrine, or history of
- •severe (allergic) reactions to mosquito bites.
- •5. Receipt of any vaccinations in the three months prior to the start of the
- •study or plans to receive any other vaccinations during the study period or up
- •to eight weeks thereafter. Exceptions are made for influenza vaccination and,
- •if it becomes available during the study period, for vaccination against the
- •novel coronavirus SARS-COV2.
- •6. Participation in any other clinical study in the 30 days prior to the start
- •of the study or during the study period.
- •7. Being an employee or student of the department of Parasitology, Medical
- •Microbiology or Infectious Diseases of the LUMC or RUMC.
- •8. Any other condition or s
研究者
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